Director, Senior Clinical Program Leader – Eye Health

This is a fully remote position, open to applicants in United States.

📋 Description

• Take complete medico-scientific and strategic charge of clinical programs.

• Expedite clinical development and secure regulatory approvals for reimbursable medicines.

• Maintain ongoing medical benefit and risk oversight for assigned assets.

• Mentor and supervise other Clinical Program Leaders as necessary.

• Spearhead the development and implementation of comprehensive evidence-generation strategies.

• Serve as Evidence Team leader, integrating deliverables from all medical functions.

• Enhance patient value, incorporate patient feedback, and improve quality of life and outcomes in line with Medicine Excellence objectives.

• Formulate and execute clinical development strategies within the broader Integrated Asset Evidence Strategies framework.

• Direct medical strategy and crucial clinical program deliverables across the clinical development lifecycle.

• Lead and integrate cross-functional evidence teams, including Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, and RWE.

• Assume responsibility for clinical development and budgeting for assigned programs.

• Present proposals and updates to both internal governance committees and external entities.

• Plan, analyze, and present clinical study data from first-in-human trials through pivotal studies.

• Ensure regional input is integrated and aligned with operational excellence.

• Conduct continuous risk/benefit assessments.

• Draft Investigator Brochures, Clinical Development Plans, key clinical trial protocols, pediatric development plans, and sections of regulatory documentation.

• Contribute to regulatory strategy and lead clinical development discussions during regulatory interactions and submissions, including IND, NDA, BLA, and MAA.

• Take the lead in authoring clinical abstracts, congress presentations, and manuscripts.

• Review and authorize project publications.

• Define the medical digital strategy and collaborate with the Digital Content Manager on tools, technologies, and best practices.

• Provide insights into Medical Affairs strategy and deliverables.

• Ensure compliance of programs with GCP requirements and global regulatory and ethical standards.

⛳️ Requirements

• MD (specialist in the relevant therapeutic area) with extensive experience across all phases of clinical drug development.

• OR PhD with over ten (10+) years of experience in the respective therapeutic area and extensive knowledge across all stages of clinical drug development.

• Strong commitment to high ethical standards and a passion for improving the lives of patients with unmet medical needs.

• In-depth knowledge of the Medicine strategy and vision.

• Thorough understanding of the therapeutic area strategy and vision.

• Capability to assess key study concepts, including background, sample size, statistics, study design, timing, feasibility, and budgeting.

• Solid medical and scientific leadership skills to drive complex and high-priority projects in collaboration with global matrix teams.

• Strong strategic thinking abilities.

• Exceptional communication, influencing, presentation, and training skills.

• Proven track record of building internal relationships and exerting influence within a matrix and virtual environment.

• Ability to establish external relationships with thought leaders and industry organizations.

• Documented experience interacting with regulatory affairs authorities, international societies, and relevant stakeholders.

• Advanced management capabilities.

• Agile and effective working style.

• Capable of stepping in for more experienced roles as needed.

• Must be legally authorized to work in the United States without any restrictions.

• Willingness to undergo a drug test and post-offer physical examination, if required.

• Must be 18 years of age or older.

🏝️ Benefits

• Competitive salary and benefits packages.

• Medical, dental, and vision insurance coverage.

• Retirement savings opportunities.

• Paid time off.

• Paid holidays.

• Disability and life insurance benefits.

• Potential for role-specific discretionary bonuses.

• Relocation assistance may be provided.

• Other company-sponsored programs available.

• Supportive and healthy working environment.

• Engaging and meaningful work.

• Opportunities for mobility and networking.

• Commitment to work-life balance.